ANZCTR search results

This research is designed specifically to compare the performance before and after exposure to the Ambu Ascope in the clinical setting for scope guided intubation. Endpoints will be GRS score, success in intubation and time taken for intubation on the first and 5th attempts with Ascope. The null hypothesis for this research project is that there is no difference in GRS score before and after 5 attempts with Ambu Ascope

The adoption of healthy school canteen policies has been recommended as a strategy to prevent excessive weight gain. A number of jurisdictions in Australia and internationally have policies requiring school adoption of healthy canteen strategies. Despite this, internationally, schools have failed to adopt healthy canteen practices consistent with such policies. If the benefits of obesity prevention initiatives are to be realised, policies recommended to prevent overweight must be implemented. However, research measuring the effectiveness of interventions to facilitate widespread implementation of health promoting policies and practices in schools is limited. The aim of the research is to assess the effectiveness of a population wide implementation intervention in increasing canteen practices consistent with the mandatory NSW government healthy canteen policy (‘Fresh Tastes @ School’). The study will employ a randomised trial design. Seventy primary schools will be randomised to receive a 12 month intervention, or a no intervention comparison group. The effectiveness of the intervention will be determined by comparing post intervention differences between canteen menus audited by Dietitians in: i) the proportion of schools with a canteen menu containing foods or beverages restricted (‘red’ items) under the policy and; ii) the proportion of schools where healthy canteen items (‘green’) represent the majority (>50%) of products listed on the menu as recommended by the policy. The proposed research will be the first RCT of its kind, addresses a questions of particular policy relevance and will make an important contribution to reducing the burden of obesity.

The primary aim of this study is to investigate the efficacy and safety of adjunctive N-acetylcysteine (NAC) in the treatment of adults (n=80) with DSM-IV diagnosed OCD in a 16-week randomised, placebo-controlled trial. The primary outcome will be between group differences the severity of OCD symptoms on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).

CardioCel is a new method to prepare and treat biological tissues used in human surgical procedures. This means that the tissue (here bovine pericardium) used to close or repair defects associated with congenital heart disease has not been approved for this purpose in Australia or in other parts of the world. This project is going to allow us to show if the CardioCel integrity is maintained. We believe the CardioCel to be equivalent to currently available patches used to repair congenital heart disease

Griseofulvin inhibits ferrochelatase (FECH). Inhibition of FECH in the red cell prevents the growth of malarial parasites. We plan a trial using griseofulvin to treat volunteers infected with malaria. This current proposed trial is a pharmacokinetics trial with two different regimen of griseofulvin, 500mg bd or a one-off bolus of 2g. The concentration of griseofulvin in red cells will be measured daily as will the ability of malarial parasites to infect cells taken from griseofulvin-treated volunteers. Haematological and clinical biochemical parameters will be followed.

A prospective, single arm, single centre, open label, clinical trial to evaluate the safety and efficacy of the Perceval S Sutureless aortic valve prosthesis. More specifically to assess: Functional performance of the valve through echocardiograms pre-operatively, intra-operatively and 5 days, 6, 12 and 24 months and 5 years post-operatively Quality of life with the SF36 pre-operatively, 6 weeks and 6 and 12 months post-operatively Mortality

Penthrox® (methoxyflurane) is an analgesic/device combination product, which is currently registered and marketed in Australia. Methoxyflurane belongs to the fluorinated hydrocarbon group of volatile anaesthetics. It is inhaled as a vapour at low (sub-anaesthetic) concentrations to provide analgesia in stable, conscious patients. hERG studies have indicated a potential for QT prolongation, a known property of this pharmacological class. However, clinical history has provided no indication that methoxyflurane may cause ventricular tachyarrhythmia or Torsades de Pointes (TdP) under conditions of use in analgesia. This study is specifically design to assess drug effects on the QT interval.

The primary aim of our study is to test whether a psycho-educational intervention, comprising a tailored, psycho-educational booklet and individual, telephone-based psychological support, will reduce fear of melanoma recurrence, defined in this study as fear of a previous melanoma coming back somewhere else in the body as well as fear of developing a new melanoma on the skin. The secondary aims of our study are to assess the cost-effectiveness of the psycho-educational intervention, and to improve patient understanding of melanoma risk, doctor-patient communication about melanoma, melanoma-related health behaviours (e.g. skin self-examination) and unmet supportive care needs. Who is it for? To participate in the study, patients will be aged over 18 years, will have a previous melanoma diagnosed at stages 0 I or II, will be attending one of the melanoma high risk clinics in New South Wales, and have sufficient English language skills to read the booklet and complete the study questionnaires. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups – the ‘intervention’ group or the ‘standard care’ group. Four weeks before their full dermatological appointment at the high risk clinic (HRC), participants in the intervention group will receive two booklets: our newly developed psycho-educational booklet (called ‘Melanoma: Questions and answers’), and the freely-available Cancer Council booklet (called ‘Understanding Melanoma’). Participants in the intervention group (Group 1) will then have three individual telephone-based psychological support sessions (each up to 90 minutes duration) with a clinical psychologist. The first telephone session will occur about one week after participants receive the booklets (before their HRC appointment). The second telephone session will occur about one week after participants’ HRC appointment, and the third telephone session will occur about three weeks after participants’’ full HRC appointment. These telephone sessions aim to give participants the opportunity to raise questions or concerns they have after reading the melanoma booklet and after attending their clinical consultation. Their key goals are to assist participants: a) to have a point of contact; b) to use the newly developed melanoma psycho-educational booklet; c) to prioritise their goals; d) to use other available avenues of support Participants in the ‘standard care’ group will receive the Cancer Council ‘Understanding melanoma’ booklet and a blank notepad, four weeks before attending their clinic appointment. All participants will be asked to complete a questionnaire at baseline (6 weeks before their full dermatological consultation at the HRC), 2 weeks after their full dermatological consultation at the HRC, and again at 6 and 12 months, to evaluate the effect of the intervention on fear of melanoma recurrence, anxiety, stress, depression, quality of life, satisfaction with clinical care, melanoma risk knowledge, healthy behavioural adjustment to melanoma risk and unmet supportive care needs.

Every year, thousands of babies are born early (premature). Many premature babies need help to breathe for several days after birth, and sometimes for much longer. The most commonly used way of supporting the breathing of premature infants is with a technique called nasal continuous positive airway pressure (NCPAP). NCPAP uses large prongs snugly fitted into the baby’s nostrils, kept in place by a tight-fitting hat. The prongs supply air or oxygen under pressure to help keep the baby’s lungs open, making it easier to breathe. NCPAP is a well-tried and tested method of breathing support, but has some disadvantages: the hat and tubing can be quite bulky and cover most of the baby’s face, and the large prongs can rub on the baby’s nose and sometimes cause damage to the skin. A newer form of breathing support being used around the world, and in Australia, is called high flow nasal cannulae (HFNC). This method uses smaller prongs in the baby’s nose and does not require a hat to hold the prongs in place. Like NCPAP, HFNC also supplies air or oxygen under pressure to help support the baby’s breathing. Because the prongs are smaller and less bulky, HFNC may be more comfortable for babies than NCPAP, and it is easier to see the baby’s face. For these reasons, HFNC has become very popular as treatment for premature babies, and is being used around the world. However, HFNC has not been widely studied as a way of supporting breathing for babies soon after birth. The HIPSTER trial will compare the use of these two types of breathing support as treatment for premature babies who have breathing difficulties soon after they have been born. Premature babies born after 28 weeks’ and before 37 weeks’ gestation, who need breathing support in the first 24 hours of life, will be able to join this study. Babies who join the study will be chosen at random to receive either NCPAP or HFNC. The study will include a total of 612 babies, 306 will be treated with each type of breathing support. The main thing we are interested in is whether babies are successfully treated with the type of breathing support they are given. Babies who are given HFNC and are not improving can be switched over to have NCPAP, to see whether that helps. Information will be collected about the babies, such as how long the babies in each group need to carry on with breathing support, whether they need extra breathing help, whether they get any damage to their nose from the prongs, and how well they feed and grow. Basic information will also be collected about the mothers of the babies and the pregnancy.

This study aims to test the safety of multiple injections of the Dz13 (combined with DOPE and DOTAP) drug in patients with melanoma skin cancer. Dz13 is a small piece of DNA which binds to an mRNA molecule c-Jun and cuts it into two pieces disrupting the production of the c-Jun protein and can lead to a reduction in growth and spread of the tumour. Who is it for? You may be eligible to join this study if you are aged 18 years or more, and have been diagnosed with dermal in-transit or satellite metastatic melanoma. You should have at least 3 measurable lesions at minimum distance of 5 cm from each other. Trial details: There will be 4 different cohorts (or groups) in this study, who are enrolled consecutively. Participants in the first group will receive 2 injections of the drug Dz13 into their tumour over a period of 1 week. Participants in the second group will receive twice weekly injections of Dz13 for two weeks, and group three for three weeks. Based on the findings of the first three groups, the fourth group will then receive twice weekly Dz13 injections for two or three weeks. All participants will be regularly assessed to determine safety and tolerability of treatment. The treated and pre-seelcted untreated tumours will be assessed by investigating the c-Jun levels within the tumour tissue and measuring tumour size. It is thought that Dz13 treatment may reduce the size of melanoma tumours in humans without significant toxicity.